MyositisBETY-BQNCT06587724
Investigation of the Validity, Reliability, and Responsiveness of the BETY-BQ in Myositis
An observational study of Myositis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Individuals diagnosed with myositis have skin, joint, and visceral organ involvement together with proximal muscle weakness, impaired physical function, sexual function, and quality of life also affect individuals psychosocially. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myositis
- What is being tested?
- Questionnaire study
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jul 2024to 31 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals who come to the university hospital for routine controls.
Who may be able to join
- Diagnosis of myositis
- To be over 18 years old
- Consent of the participant
Who cannot join
- Uncontrolled/other clinically significant disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.) individuals with a diagnosis,
- Pregnant individuals,
- Individuals with malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Altındağ, 06100
Orkun Tüfekçi, PT, PhD(c), +90 312 305 25 25, orkuntf@gmail.com
About this study
Official title: Investigation of the Validity, Reliability, and Responsiveness of the BETY-Biopsychosocial Questionnaire in Individuals Diagnosed with Myositis
Individuals diagnosed with myositis have skin, joint, and visceral organ involvement together with proximal muscle weakness, impaired physical function, sexual function, and quality of life also affect individuals psychosocially. Increased anxiety-depression-anxiety problems are observed in individuals, and many factors contributing to these conditions are reported. Therefore, while holistic evaluation of individuals, including these factors, gains importance, more information on how the quality of life changes during the disease is required. There is a need for tools to evaluate these characteristics in individuals disease management and treatment process.
The cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise model based on physical exercise and an example of a biopsychosocial approach developed in patients with rheumatism. The BETY-Biopsychosocial Questionnaire (BETY-BQ) was created by repeated statistics of the improvement characteristics reported by individuals who participated in BETY sessions for many years. The BETY-BQ holistically evaluates many biopsychosocial characteristics of the individual, such as pain, coping skills, functionality, mood, sociability, sexuality, and sleep. Therefore, there is a need for scales that holistically evaluate the symptoms mentioned in myositis disease. Since the BETY-BQ can assess biopsychosocial characteristics quickly and its structure was created with the feedback of individuals with chronic disease, it aimed to examine its validation in this disease group.
This study, which the investigators planned to contribute to this field, aims to investigate BETY-BQ^s validity, reliability, and responsiveness in individuals diagnosed with myositis.
- Conditions
- Myositis
- Being tested
- Questionnaire study
- Keywords
- myositis, biopsychosocial model, validity and reliability, BETY-BQ, muscle strenght, pain
- Medical subject headings
- Myositis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire studyOther
Also called BETY-Biopsychosocial Questionnaire
Questionnaire application
What is being measured
The primary outcome is the main question the study is designed to answer.
BETY-Biopsychosocial Questionnaire
The biopsychosocial status of the individual is assessed with questions about pain, functionality, mood, sociability, sexuality, and sleep status. Each question consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status
Measured: Three months
Secondary outcomes (12)
Hospital Anxiety Depression Scale
It consists of 14 items, 7 of which assess anxiety, and the other 7 determine depression. Each item is scored between 0-3, and the total is scored between 0-21. High scores indicate poor anxiety and depression levels.
Measured: Three months
Myositis Disease Activity Assessment Tool (MDAAT)
The Myositis Disease Activity Assessment Tool (MDAAT) is a tool that assesses the disease activity of non-muscle organ systems and muscles in patients with myositis. The MDAAT combined tool includes the Myositis Disease Activity Assessment VAS (MYOACT) and the Myositis Activities Index for Therapeutic Purposes (MITAX). MYOACT is a series of physician judgments of disease activity in various organ systems using a VAS to assess the severity of disease activity. MITAX indicates disease damage from myositis, in the physician\'s opinion. For MYOACT, each organ system receives a score of 0-10, and the six non-muscular organ systems are summed to obtain an extra-muscular score of 0-60 or a total score including the muscular system ranging from 0-60. For MITAX, each question is scored 0 = not available; 1 = improvement; 2 = same; 3 = worse; 4 = new. The organ system scores are summed to obtain a total MITAX score of 0-63 or 0-54 if the muscular system is excluded.
Measured: Three months
Health Assessment Questionnaire
The Health Assessment Questionnaire evaluates the functionality of the individual using eight parameters and 20 items. The parameters are classified as dressing, standing, eating, walking, hygiene, reaching, grasping, and other activities. Each item is scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with a lot of difficulty), and 3 (unable to do at all). The total score is between 0-3, with a high score indicating low functionality.
Measured: Three months
Dermatology Life Quality Index
Ten questions assess the quality of life-related to dermatological findings. The first and second questions are about symptoms and feelings, the third and fourth questions are about daily activities, the fifth and sixth questions are about leisure time activities, the seventh question is about work and school, the eighth and ninth questions are about interpersonal relationships and the tenth question is about treatment. The items are scored as 3 (quite a lot), 2 (very much), 1 (slightly), 0 (not at all), 0 (not relevant) between 0-30. A high score indicates a decrease in quality of life.
Measured: Three months
Hand Dynamometer
Muscle strength will be measured with a hand dynamometer (Lafayette Instrument®, Lafayette, IN) routinely used in the rheumatological rehabilitation unit. The dynamometer allows maximal isometric strength to be measured objectively and reliably using a standardized protocol. High values indicate a high strength value. In our study, deltoid, biceps, wrist extensors, quadriceps, gluteus maximus, gluteus medius, ankle dorsiflexion, and neck flexors isometric muscle strength values will be measured with a hand dynamometer in the appropriate evaluation position for each muscle. For each position, three measurements (3 seconds of contraction, 30 seconds of rest) will be made, and mean values will be calculated.
Measured: Three months
Timed Up and Go Test
The balance status of the individual is evaluated by getting up from a back-supported chair and walking 3 meters at a normal walking speed and returning to the chair and the time of sitting on the chair is measured and recorded in seconds.
Measured: Three months
30 Seconds Sit to Stand Sest
To evaluate lower extremity strength, the individual stands upright on a chair with his/her arms crossed on his/her chest and then sits down again. The individual is asked to repeat at his/her own pace for 30 seconds. The score of this assessment test is the number of times the individual stands up fully from a sitting position with arms crossed within 30 seconds.
Measured: Three months
10-Metre Walk Test
The individual is asked to walk quickly without running on a 10-metre path. It is recorded in seconds in the evaluation made with three repetitions.
Measured: Three months
Short Form-36
Quality of life is a 36-item generic scale that assesses the quality of life with eight parameters (physical functioning, social functioning, role limitations due to physical complaints, role limitations due to emotional problems, mental health, energy-vitality, bodily pain (BP), general health perception), each parameter is scored between 0-100. A high score indicates a good quality of life.
Measured: Three months
Visual Analogue Scale
The individual diagnosed with myositis will asked to show the pain, fatigue, and disease activity status in the last week on a 10 cm long Visual Analogue Scale (VAS). A high score shows worse pain, fatigue, and disease activity status.
Measured: Three months
Manual Muscle Test-8
The Manual Muscle Test-8 (MMT-8) is one of the most popular instruments for measuring muscle strength. It is a shorter version of the original instrument in which the individual^s eight dominant proximal, distal, and axial muscle groups are tested unilaterally. Each muscle group examined is scored from 0-10 (0 = extreme weakness and 10 = normal strength) depending on how much it can move against gravity or pressure applied by the examiner.
Measured: Three months
Stair Climb Test
To measure the individual^s lower extremity strength and dynamic balance, the time to ascend and descend a 10-step staircase with a handrail in the range of 16-20 cm as fast as possible is recorded in seconds.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Jul 2024
- Primary completion24 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyositisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkun Tüfekçi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587724
- Sponsor's protocol ID
- SBA 24/533
- Acronym
- BETY-BQ
- Status last verified
- Sep 2024
- First submitted
- 31 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared to protect the data of individuals
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Validity, Reliability, and Responsiveness of the BETY-Biopsychosocial Questionnaire in Individuals Diagnosed with Myositis
- ClinicalTrials.gov ID
- NCT06587724
- Acronym / sponsor ID
- BETY-BQ / SBA 24/533
- Conditions
- Myositis
- Keywords
- myositis, biopsychosocial model, validity and reliability, BETY-BQ, muscle strenght, pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals diagnosed with myositis have skin, joint, and visceral organ involvement together with proximal muscle weakness, impaired physical function, sexual function, and quality of life also affect individuals psychosocially. Increased anxiety-depression-anxiety problems are observed in individuals, and many factors contributing to these conditions are reported. Therefore, while holistic evaluation of individuals, including these factors, gains importance, more information on how the quality of life changes during the disease is required. There is a need for tools to evaluate these characteristics in individuals disease management and treatment process.
The cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise model based on physical exercise and an example of a biopsychosocial approach developed in patients with rheumatism. The BETY-Biopsychosocial Questionnaire (BETY-BQ) was created by repeated statistics of the improvement characteristics reported by individuals who participated in BETY sessions for many years. The BETY-BQ holistically evaluates many biopsychosocial characteristics of the individual, such as pain, coping skills, functionality, mood, sociability, sexuality, and sleep. Therefore, there is a need for scales that holistically evaluate the symptoms mentioned in myositis disease. Since the BETY-BQ can assess biopsychosocial characteristics quickly and its structure was created with the feedback of individuals with chronic disease, it aimed to examine its validation in this disease group.
This study, which the investigators planned to contribute to this field, aims to investigate BETY-BQ^s validity, reliability, and responsiveness in individuals diagnosed with myositis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals who come to the university hospital for routine controls.
Key inclusion criteria (3 listed)
- Diagnosis of myositis
- To be over 18 years old
- Consent of the participant
Key exclusion criteria (3 listed)
- Uncontrolled/other clinically significant disease (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.) individuals with a diagnosis,
- Pregnant individuals,
- Individuals with malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire studyAlso: BETY-Biopsychosocial QuestionnaireQuestionnaire application | Other | – |
Primary outcome
BETY-Biopsychosocial Questionnaire
Time frame: Three months
The biopsychosocial status of the individual is assessed with questions about pain, functionality, mood, sociability, sexuality, and sleep status. Each question consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status
12 secondary outcomes
Hospital Anxiety Depression Scale
Time frame: Three months
Myositis Disease Activity Assessment Tool (MDAAT)
Time frame: Three months
Health Assessment Questionnaire
Time frame: Three months
Dermatology Life Quality Index
Time frame: Three months
Hand Dynamometer
Time frame: Three months
Timed Up and Go Test
Time frame: Three months
30 Seconds Sit to Stand Sest
Time frame: Three months
10-Metre Walk Test
Time frame: Three months
Short Form-36
Time frame: Three months
Visual Analogue Scale
Time frame: Three months
Manual Muscle Test-8
Time frame: Three months
Stair Climb Test
Time frame: Three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Will not be shared to protect the data of individuals
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Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
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A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
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A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myositis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Orkun Tüfekçi, PT, PhD (c) (5319502648, orkuntf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BETY-Biopsychosocial Questionnaire (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.